The use of suction devices to remove fluids from a wound is known to the art. Such devices are employed to reduce or remove the body fluids which normally collect at a wound site after surgery.
Body fluids which collect at a wound, if left to remain especially in a closed wound, may cause complications in the healing process and thereby reduce the chance of a successful convalescence. Moreover, not only will a dry wound area accelerate the healing stage but will also promote cicatrization.
Known typical suction devices are both disclosed and illustrated in Canadian Pat. No. 879,849; British Pat. No. 1,304,324 to Astra-Meditec; British Pat. No. 1,400,139 to Mathys; U.S. Pat. No. 3,115,138 to McElvenny et al.; U.S. Pat. No. 3,376,868 to Mondiadis; U.S. Pat. No. 3,742,952 to Magers et al.; U.S. Pat. Nos. 3,774,611 and 3,779,249 to Tussey et al.; U.S. Pat. No. 3,809,086 to Schachet et al.; U.S. Pat. No. 3,809,087 to Lewis, Jr.; and U.S. Pat. No. 3,875,941 to Adair.
With reference to the Canadian patent, the device disclosed therein includes a container with a concertina-pleated wall that can be expanded to increase the volume of the container. A detachable external spring bow serves to extend the pleated wall thereby causing suction within the container. The concertina-pleated walls are consecutively numbered to permit measurement of the fluid collected when the container is in an open, extended position.
The Astra-Meditec patent discloses a bellows operated disposable aspiration drainage device. A non-return inlet valve permits the collection of body fluids into the bellows from an inlet catheter connected to the wound to be drained. The collected body fluids are discharged through a non-return outlet valve into a receiving bag. The latter is graduated to allow measurement of removed body fluids.
The Mathys patent discloses a suction drainage device which includes a resiliently compressible, airtight container having a watertight plastic bag detachably secured therein. The container upon expansion produces a negative pressure which results in the flow of body fluids into the bag within. A helical spring can be used inside the container to provide expansion of the container.
The McElvenny patent discloses an evacuator that includes a fluid tight container. After manual compression, the container is expansible to provide suction either by means of internally positioned springs between additional members placed within the container or by virtue of the container being constructed of resilient material.
The evacuator disclosed in the Mondiadis patent includes a compressible container made from resilient elastomeric material whose memory causes the walls to return to an uncompressed state. A valve turret on the top of the container provides both an inlet and a vent opening which is sealable by means such as a plug or a resilient diaphragm connected to the top.
The Magers et al. patent discloses a surgical suction assembly including a suction container which is resiliently compressible and expansible. A one way plug is provided to admit fluid into the container while drawing fluid and to block flow outwardly therefrom.
The Tussey '611 patent discloses a contamination free evacuator including a compressible-expandable container having an inlet and an outlet region, and a fluid stabilizer inside the container.
A contamination free evacuator is also disclosed in the Tussey '243patent which includes a compressible and expandable evacuator bag having both a drain inlet and an exhaust outlet formed in the bag. The latter further includes a magnetic one-way exhaust valve which prevents the contamination of the bag by closing upon completion of exhausting fluids from the bag.
The Schachet et al. patent is directed to a wound suction device including a vessel having therein an elastic sheet diaphragm which is sealed to the walls of the vessel. Movement of the diaphragm by a plate with an actuating means decreases the volume of the vessel which results in the creation of a suction force upon release of the actuating means. Provision is made to lock the actuator means in a position such that the resilient diaphragm remains displaced.
In the Lewis patent, a suction apparatus is disclosed having a collapsible bag attached at opposed surfaces to plate members one of which is biased to move away from the other plate member. Disclosed biasing means include springs and rubber bands.
The evacuating system disclosed in the Adair patent includes a bellows-type container having resilient accordian-like sidewalls made of an elastomeric material. Initial suction of the container is provided by the resilient accordian-like sidewalls. Further suction results from the added weight of collected fluid within the container. Operation of this system requires that the bellows-type container be mounted in a vertical position with evacuating tubing attached to the top portion of the container.
Although each of the above-mentioned patented devices is useful in varying degrees, they all suffer from some of several disadvantages which include, e.g., the necessity of activation just prior to use, the lack of ease in operation, the need of resilient containers or component members, complex structure, and the inability to maintain a substantially constant level of negative pressure.
All of the above patents except Schachet provide no disclosure of a device which can be received by the handler in a preactivated or compressed state. These devices require that the handler collapse the bellows or container to activate the device before use. Difficulty in operation is presented particularly in the Astra-Meditec apparatus, the Canadian drain, and the Adair device. The Astra-Meditec apparatus discloses a directional multicomponent valve system which requires that the handler properly connect the device to the wound and the collecting bag. Multi-component complex valve arrangements are also disclosed in the Magers valve means and the Tussey '243 magnetic exhaust valve. The Canadian drain not only requires that the user compress the concertina-pleated walls to drain air from the device but also that an external spring bow be attached further complicating the operation thereof. In the Adair device, difficulty arises from the requirements that the device be maintained upright for proper operation. Increased cost of operation or construction results from the multi-component or complex valve systems disclosed in the Astra-Meditec, Magers, and Tussey '243 patents; and from the need of additional collecting bags in the Astra-Meditec and Mathys patents. Resilient retaining containers or component members are disclosed in one form or another in most of the above patents. Complex structure is formed in the multiple spring arrangement disclosures of the McElvenny, Tussey '243, and Lewis patents, and in the need of a fluid stabilizer as disclosed in the Tussey '611 patents. Such complex structures complicate construction as well as increase the cost thereof. Finally, none of the above patents disclose a device providing substantially constant suction over the range of operation. The spring means disclosed in the Canadian, Mathys, McElvenny, Tussey '243, and the Lewis device do not allow for a substantially constant suction operation.